Device recall: A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF…
Class III FDA enforcement event 91054. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Primus Corporation dba Trinity Biotech started this device recall on 5 Oct 2021. The firm address in the FDA record is in Kansas City, MO. FDA put the recall in Class III. FDA event 91054 has 2 product records. The first FDA enforcement report date is 7 Dec 2022. The record gives the status Terminated, with the termination date 9 Aug 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
Recalling firm
Primus Corporation dba Trinity Biotech, Kansas City, MO.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0349-2023 | A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis | 340 kits | Class III | Terminated | 7 Dec 2022 |
| Z-0350-2023 | Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis | 182 kits | Class III | Terminated | 7 Dec 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class III
- 3%
- Product records in this event
- 2
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-0349-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 91054. https://recallregister.com/fda/iii/91054/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy.
- What quantity of product is in FDA event 91054?
- The event has 2 product records. The first record gives this quantity:
340 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 3% of the 900 device events that started in 2021 are in Class III.